Diasorin, Saluggia Italy 23-Dec-99 production/QC software validation for reagents”8. Failure to ensure that all equipment used in the manufacturing process meets specified requirements and is appropriately designed, constructed, placed, and installed to facilitate maintenance, adjustment, cleaning, and use [21 CFR 820.70(g)] in that the Gamma Counter Data Transfer Validation, dated March 31. 1999. did not...Read More